Open Access

Modulated electro‑hyperthermia with weekly paclitaxel or cisplatin in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: The KGOG 3030 trial

  • Authors:
    • Kidong Kim
    • Jae-Hoon Kim
    • Seung Cheol Kim
    • Yong Beom Kim
    • Byung-Ho Nam
    • Jae  Hong No
    • Hanbyoul Cho
    • Woong Ju
    • Dong Hoon Suh
    • Yun Hwan Kim
  • View Affiliations

  • Published online on: May 21, 2021     https://doi.org/10.3892/etm.2021.10219
  • Article Number: 787
  • Copyright: © Kim et al. This is an open access article distributed under the terms of Creative Commons Attribution License.

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Abstract

The present study (KGOG 3030) aimed to evaluate the safety of modulated electro‑hyperthermia (mEHT) therapy with weekly administration of paclitaxel or cisplatin in female patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma. A total of 12 patients were randomized into the paclitaxel or cisplatin arm at a 1:1 ratio. Patients received weekly administration of paclitaxel (70 mg/m2) or cisplatin (40 mg/m2) intravenously on days 1, 8 and 15, and underwent mEHT therapy for 1 h on days 1, 4, 8, 11, 15, 18, 21 and 24 for each 4‑week cycle. The primary endpoint was the occurrence of dose‑limiting toxicity (DLT). The secondary endpoints were treatment‑emergent adverse events (TEAEs), objective response rate, carbohydrate antigen 125 (CA125) response rate, progression‑free survival (PFS) and overall survival (OS). In total, 16 patients were recruited, but four patients dropped out. None of the 12 remaining patients (6 each in the two arms) experienced DLT. Overall, 0 and 4 grade 3 TEAEs (anemia, nausea, neutrophil count decreased and platelet count decreased) occurred in the paclitaxel and cisplatin arm, respectively. Furthermore, one confirmed partial response and two CA125 responses were observed in the cisplatin arm. The median PFS time in the paclitaxel and cisplatin arms was 3.0 months (range, 1.7‑4.6 months) and 6.8 months (range, 3.9‑11.8 months), respectively, while the median OS time was 11.5 months (range, 8.4‑28.8+ months) and not reached (range, 3.9‑38.5+ months), respectively. In conclusion, mEHT therapy with weekly paclitaxel or cisplatin appeared safe and warrants further investigation. The present trial was registered with www.clinicaltrials.gov on January 22, 2015 (trial registration no. NCT02344095).
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July-2021
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Spandidos Publications style
Kim K, Kim J, Kim SC, Kim YB, Nam B, No JH, Cho H, Ju W, Suh DH, Kim YH, Kim YH, et al: Modulated electro‑hyperthermia with weekly paclitaxel or cisplatin in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: The KGOG 3030 trial. Exp Ther Med 22: 787, 2021
APA
Kim, K., Kim, J., Kim, S.C., Kim, Y.B., Nam, B., No, J.H. ... Kim, Y.H. (2021). Modulated electro‑hyperthermia with weekly paclitaxel or cisplatin in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: The KGOG 3030 trial. Experimental and Therapeutic Medicine, 22, 787. https://doi.org/10.3892/etm.2021.10219
MLA
Kim, K., Kim, J., Kim, S. C., Kim, Y. B., Nam, B., No, J. H., Cho, H., Ju, W., Suh, D. H., Kim, Y. H."Modulated electro‑hyperthermia with weekly paclitaxel or cisplatin in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: The KGOG 3030 trial". Experimental and Therapeutic Medicine 22.1 (2021): 787.
Chicago
Kim, K., Kim, J., Kim, S. C., Kim, Y. B., Nam, B., No, J. H., Cho, H., Ju, W., Suh, D. H., Kim, Y. H."Modulated electro‑hyperthermia with weekly paclitaxel or cisplatin in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: The KGOG 3030 trial". Experimental and Therapeutic Medicine 22, no. 1 (2021): 787. https://doi.org/10.3892/etm.2021.10219